MHRA-100229-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • NINTEDANIB
Invented Name
  • Ofev
  • Vargatef
  • Ofev
  • Vargatef
PIP Number MHRA-100229-PIP01-21-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Capsule, soft
Therapeutic area
  • Pneumology - Allergology
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of fibrosing Interstitial Lung Diseases (ILD)
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):NINTEDANIB.pdf
Published Date 17/05/2022